Rethinking the regulation of digital contraception under the medical devices regime

Abstract

Contraceptives are vital healthcare for women and people with wombs. Recently, there has been a rise in the use of ‘digital contraceptives’, a type of ‘femtech’ software available for download on app stores which require data input in order to make predictions about users’ fertility. Digital contraceptives, when marketed as such, fall within the definition of a ‘medical device’ and under the authority of the Medical Devices Regulations 2002 are a ‘medium-risk’ device. However, not all femtech which may be used as contraception are captured by this framework. In this article, it is argued that the regulatory category into which digital contraceptives have been placed by the medical devices regime is (a) unduly limited in scope, (b) insufficiently stringent to protect users considering the grave and life-changing effects this technology can have if things go wrong, and (c) ill-conceived as a regulatory response to a technology that affects large sections of the population. It is suggested here that the broader context in which software as a contraceptive sits (i.e. within the general contraceptive market) is key to understanding the regulatory blindness that is occurring when it comes to digital contraceptives and some other forms of fertility-related femtech. As such, software which can be used as a contraceptive are in fact ‘high risk’ and should be reclassified as such.

"“My sex-related data is more sensitive than my financial data and I want the same level of security and privacy\": User Risk Perceptions and Protective Actions in Female-oriented Technologies"

“…Several recent papers (e.g., [42]) have shown and discussed how the gray area in different laws (general data protection, health, and medical systems and devices) and lack of coverage for FemTech data provide opportunities to exploit the user data. The 'Data Protection by Design and by Default' (DPbD) is defined by the GDPR as a requirement for the service providers to put in place appropriate technical and organisational measures to implement the data protection principles effectively and safeguard individual rights [4].…”

Fertility apps, datafication and knowledge production in reproductive health

“…Even though FAM knowledge is adapted by digital apps, how this is done, what constitutes a baseline standard in tracking and which method is most effective remains an open question, thus leading to continued practices of legitimation. Emerging legal scholarship, nonetheless, argues for a more forceful and robust regulation of such devices (McMillan, 2023).…”

Exploring the Use and Implications of AI in Sexual and Reproductive Health and Rights: Protocol for a Scoping Review

“…In addition, the use of AI to power “software as a medical device” [ 15 ] presents an opportunity to leapfrog access to diagnostic devices, such as ultrasounds [ 16 ] and blood pressure equipment [ 17 ]. This has also been seen with the emergence of contraceptive and fertility software applications [ 18 , 19 ], which are increasingly securing regulatory approvals from national authorities [ 20 , 21 ].…”